Father Inclusive Prenatal Care for Pregnancy

(FIPC Trial)

Overseen By Wrenetha A Julion, PhD, MPH, RN

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Non-English/Spanish, Cognitive disability

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to support young families by helping expectant fathers develop parenting and relationship skills through Father Inclusive Prenatal Care. The program provides parent education, co-parenting classes, and employment support to prepare young parents for the challenges of raising a child. The trial seeks pregnant women and their partners willing to participate in a joint interview. Services aim to improve co-parenting relationships and prepare couples to care for their infants. Most offerings are available online, making access easier for participants. As an unphased trial, this study offers families a unique opportunity to gain valuable skills and support during a crucial time.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Father Inclusive Prenatal Care model is safe?

Research has shown that programs involving fathers in prenatal care are generally safe and well-received. Studies indicate these programs can enhance relationships and parenting skills without causing harm. No reports of negative effects from the programs themselves exist. They focus on education and support, which do not cause any problems. Instead, they aim to help fathers and families prepare for the challenges of parenting. Since this trial phase is labeled "Not Applicable," it likely focuses on program delivery rather than safety testing, as these are educational services, not medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Father Inclusive Prenatal Care because it takes a holistic approach to supporting expectant fathers, which is not typically emphasized in standard prenatal care. Unlike traditional prenatal care that often focuses solely on the mother's health, this approach includes co-parenting and parenting education, along with employment and educational readiness training for fathers. By involving fathers more comprehensively, this treatment aims to improve outcomes for both parents and their child, promoting a more supportive family environment from the start.

What evidence suggests that the Father Inclusive Prenatal Care model is effective for preparing young parents for parenthood?

Studies have shown that including fathers in prenatal care, such as the Father Inclusive Prenatal Care program studied in this trial, can improve outcomes for mothers, fathers, and babies. Research indicates that when dads are involved, they develop better relationship skills and feel more ready for parenting. Programs involving fathers are linked to better teamwork between parents and stronger bonds with their children. Fathers who participate often feel more prepared for parenthood and help create a stable family environment. These benefits can lead to healthier settings for babies and more supportive families. ^{1 2 4 5 6}

Who Is on the Research Team?

Wrenetha A Julion, PhD, MPH, RN, CNL, FAAN

Principal Investigator

Rush University Medical Center

Paul w Florsheim, PhD

Principal Investigator

University of Wisconsin, Milwaukee

Are You a Good Fit for This Trial?

This trial is for first-time pregnant women and their partners who are willing to participate together in an interview. It's not open to those who don't speak English or Spanish, or have cognitive disabilities that affect understanding of the consent process.

Inclusion Criteria

My partner and I are willing to participate in the initial interview together.

I am a pregnant woman who has never given birth.

Exclusion Criteria

Men and Women with language other than Spanish or English and cognitive disability interfering with ability to understand the informed consent process.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Parent Prep Check (PPC)

Engagement of young fathers and mothers in research and intervention activities, including a semi-structured interview and motivational interviewing approach

3 hours

1 visit (in-person)

Father Inclusive Prenatal Care (FIPC) Program

Participants receive co-parenting, parenting education, and employment and educational readiness training and support

6 months

Multiple visits (online and in-person)

Follow-up

Participants are monitored for relationship quality, emotional intelligence, parenting stress, and paternal involvement at 6 and 18 months post birth

18 months

Follow-up assessments at 6 and 18 months post birth

What Are the Treatments Tested in This Trial?

Interventions

• Father Inclusive Prenatal Care

Trial Overview The study tests a Father Inclusive Prenatal Care model aimed at preparing young men for parenting by enhancing relationship skills within routine prenatal care. This includes parent education, co-parenting programs, and support with education and employment.

How Is the Trial Designed?

Group I: Father Inclusive Prenatal Care Experimental Treatment 1 Intervention

Co parenting, parenting education, employment and educational readiness training and support.

Father Inclusive Prenatal Care is already approved in United States for the following indications:

Approved in United States as FIPC for:

• Supporting young families in prenatal care
• Improving co-parenting relationships
• Preparing young parents for parenthood

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Skills for Chicagoland's Future-Chicago

Collaborator

Trials

1

Recruited

250+

Parent Child Center (PCC) Community Wellness Center

Collaborator

Trials

1

Recruited

250+

Children's Bureau - Administration for Children and Families

Collaborator

Trials

23

Recruited

40,900+

Advocate Health Care

Collaborator

Trials

57

Recruited

1,412,000+

University of Wisconsin, Milwaukee

Collaborator

Trials

52

Recruited

6,200+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

A structured engagement study involving community leaders and new fathers was conducted to inform the development of a father-inclusive intervention for infant obesity prevention, highlighting the importance of including fathers in health initiatives.

Feedback from stakeholders revealed that tailoring program delivery to address the specific social-emotional needs of new parents can enhance the effectiveness of obesity prevention efforts, ultimately leading to better health outcomes for families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder engagement in developing a father-inclusive early life obesity prevention intervention: First Heroes. Silver, SR., Whooten, RC., Kwete, GM., et al.[2022]

The family-centred consultation approach in postnatal care was found to be effective, helping both mothers and fathers feel more secure and confident in managing their new roles with their baby.

Fathers reported feeling included in the postnatal care process from the start, highlighting the importance of family nursing in promoting involvement and support for both parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Young first-time parents' experiences with family-centred postpartal health care in Switzerland]. Kläusler-Troxler, M., Kurth, E., Spirig, R.[2014]

Experienced community interventionists, even without formal couples' therapy training, can effectively deliver a manualized prenatal intervention to unmarried parents, achieving acceptable levels of fidelity in their sessions.

Parents reported satisfaction with the intervention and showed significant improvements in family dynamics three to four months after treatment, highlighting the importance of involving fathers in prenatal coparenting support, even in non-cohabiting situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prenatal Coparenting Intervention With Unmarried Father-Mother Dyads: Fidelity of Intervention Delivery by Male-Female Community Mentor Teams. Salman-Engin, S., Little, T., Gaskin-Butler, V., et al.[2018]

A study involving 962 adult males showed that men recognize the importance of being involved in prenatal health, despite facing barriers like time constraints and unclear roles.

The majority of participants found an eHealth app for new and expectant fathers useful and expressed a desire for more interactive features, indicating a strong acceptance of digital tools to engage men in supporting healthy pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Men in Prenatal Health via eHealth: Findings From a National Survey. Mackert, M., Guadagno, M., Lazard, A., et al.[2020]

The PRENACEL program, which uses SMS technology to provide health education to partners of pregnant women, significantly increased their participation in prenatal consultations and support during childbirth compared to control groups.

With a 53.4% adherence rate, the program demonstrated good acceptability and suggests that communication technology can effectively enhance men's involvement in prenatal and postpartum care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PRENACEL partner - use of short message service (SMS) to encourage male involvement in prenatal care: a cluster randomized trial. Bonifácio, LP., Franzon, ACA., Zaratini, FS., et al.[2021]

Paternal involvement in prenatal care is crucial and can lead to positive long-term outcomes for children, emphasizing that fathers play an important role from conception through pregnancy and beyond.

The paper suggests that clinicians should actively promote and encourage fathers' engagement in prenatal care to foster responsibility and support for both the mother and child.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatherlessness Begins Prenatally: A Scoping Review. Sandler, R.[2023]

The Family Integrated Care (FICare) program in Alberta's NICUs positively influenced the experiences of fathers of preterm infants, enhancing their confidence and involvement during their infants' hospital stay and beyond.

Fathers reported feeling more supported and engaged due to effective communication and the opportunity to identify their roles, suggesting that FICare can lead to better family dynamics and parenting experiences after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fathers' Experiences in Alberta Family Integrated Care: A Qualitative Study. Shafey, A., Benzies, K., Amin, R., et al.[2023]

Citations

1. aha.org aha.org/news/blog/2025-10-28-preparing-fathers-parenthood-prenatal-program-supporting-dads-moms-and-babies

A Prenatal Program Supporting Dads, Moms, and Babies Father-inclusive prenatal care is reshaping maternal and infant health outcomes. In this conversation, Wrenetha Julion, Ph.D., R.N. of Rush ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10330563/

Effectiveness of father-inclusive interventions on maternal ... Interventions that include fathers and other male caregivers have potential to improve maternal and paternal caregiving, couple's relationships dynamics, and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05652387

NCT05652387 | Father Inclusive Prenatal Care Study The Father Inclusive Prenatal Care (FIPC) model is designed to prepare young men for the challenges of parenting by supporting the development of their ...

4. rushu.rush.edu rushu.rush.edu/research-rush-university/departmental-research/college-nursing-research/funded-projects/preparing-parenthood-father-inclusive-model-prenatal-care

Preparing for Parenthood: A Father Inclusive Model of ... The Father Inclusive Prenatal Healthcare (FIPH) model is designed to prepare young men for the challenges of parenting by supporting the development of their ...

5. cuph.org cuph.org/fipc.html

FIPC Unlike many father focused programs, FIPC is delivered using a prenatal care model, delivering services couple by couple rather than in groups. This allows us ...

6. publications.aap.org publications.aap.org/pediatrics/article/142/1/e20180437/37506/Father-Inclusive-Perinatal-Parent-Education

Father-Inclusive Perinatal Parent Education Programs Available programs were associated with increased father involvement, coparenting relationship, partner relationship quality, father's mental ...